Miniature ingestible device

ABSTRACT

The present invention discloses multiple approaches to preventing the capsule walls and other material from interfering with the performance of an electronic device once the device is activated by surrounding fluid. In accordance with the teachings of the present invention, a miniature ingestible device (MID) may be created using excipients and films. The MID, in accordance with various aspects of the present invention, will have a coating or laminating surrounding an electronic device and separating and isolating the device from the pharmaceutical product or drug within the capsule once the capsule is ingested as well as from the capsule itself as the capsule walls begin to collapse during the disintegration process.

RELATED APPLICATIONS

Pursuant to 35 U.S.C. § 119 (e), this application claims priority to thefiling date of U.S. Provisional Patent Application Ser. No. 61/321,846filed on Apr. 7, 2010 entitled MINIATURE INGESTIBLE EVENT MARKER INTABLET, and U.S. Provisional Patent Application Ser. No. 61/416,150filed on Nov. 22, 2010 entitled INGESTIBLE DEVICE WITH PHARMACEUTICALPRODUCT, the disclosures of which applications are herein incorporatedby reference.

This application is related to and incorporates the followingapplications, including content incorporated therein, by reference: (A)U.S. patent application Ser. No. 12/564,017 entitled COMMUNICATIONSYSTEM WITH PARTIAL POWER SOURCE and filed on Sep. 21, 2009 andpublished as US-2010/0081894; (B) U.S. Application numberPCT/US12/447,172 filed on Oct. 25, 2007 and titled “CONTROLLEDACTIVATION INGESTIBLE IDENTIFIER.” and published as US-2010-0239616.

FIELD OF INVENTION

The present invention relates to electronic devices and, morespecifically, to electronic devices for use with a pharmaceuticalproduct.

BACKGROUND

Capsules are made of a material that becomes gel-like once in contactwith fluids. Such gel-like materials can interfere with the operation ofan ingestible device that relies upon contact with the surrounding fluidwhen the device is carried inside the capsule. For example, gelatinousmaterials have low conductivity and, hence, if the device operates usingconduction through fluids, then it will not operate properly. Thus, itis important to prevent the gel-like material of the capsule, as it isdisintegrating, from coming into contact with the device's components.

Additionally, capsules contain pharmaceutical materials that caninteract with or damage the device. For example, as the capsuledisintegrated, the pharmaceutical material will dissolve into thesurrounding fluid and change the chemical composition of the fluidimmediately surrounding the pharmaceutical material and the change mayprevent the device from operating optimally. The content of the capsulemay include material, such as a drug or excipient or compound, that whendissolved at high concentrations, will interfere with the operation ofthe ingested device placed within the same capsule. As the materialenters the solution at the site where the capsule is dissolving, thereis a high concentration localized around the device. The stomach motionand diffusion disperses the capsule content throughout the stomach andreduces the concentration. During this time, the device will not operateproperly optimally if activated in the localized high concentrationareas.

Also, during long term storage the pharmaceutical material may begin tointeract with the device and prevent optimal performance when the deviceis activated. For example, the product inside the capsule may be acidicand harmful to the electronic components. Alternatively, the content maybe too basic, which can also harm the electronics. Furthermore, thematerial or product within the capsule will start to interact with thesurrounding fluids, once the capsule is ingested and the capsule startsto disintegrate.

Therefore, what is needed is a device that is manufactured andassembled, such that the capsule walls or other materials present in thefluid environment immediately surrounding the device do not interferewith optimal performance of the device.

SUMMARY

The present invention discloses multiple approaches to preventing thecapsule walls and other material from interfering with the performanceof a device once the device is activated by surrounding fluid.

DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a capsule containing a miniature ingestible device and anactive agent in accordance with the present invention.

FIG. 2A shows a miniature ingestible device with a powder excipient inminiature tablet form in accordance with one aspect of the presentinvention.

FIG. 2B shows a miniature ingestible device with a film and powder inthe form of a miniature tablet in accordance with one aspect of thepresent invention

FIG. 2C shows a miniature ingestible device with a film in accordancewith one aspect of the present invention.

FIG. 2D shows a miniature ingestible device with a powder glued to aningestible device in accordance with one aspect of the presentinvention.

FIG. 2E shows a miniature ingestible device with a film in accordancewith one aspect of the present invention.

FIG. 2F shows a miniature ingestible device with a film surrounded by apowder in accordance with one aspect of the present invention.

FIG. 3 shows a capsule containing a miniature ingestible device and anactive agent prior to coming in contact with a fluid.

FIG. 4 shows the capsule of FIG. 3 at the initial stage on contactingthe fluid with the walls of the capsule beginning to collapse and theminiature ingestible device in accordance with the present invention.

FIG. 5 shows the capsule of FIG. 4 at a more advanced stage of being incontact with the fluid in accordance with the present invention.

FIG. 6 shows an assembly unit for creating a miniature ingestible devicein accordance with the present invention.

FIG. 7 shows an assembly unit for creating a miniature ingestible devicein accordance with the present invention.

FIG. 8 shows an assembly unit for creating a miniature ingestible devicein accordance with the present invention.

FIG. 9 shows an assembly unit for creating a miniature ingestible devicein accordance with the present invention.

FIG. 10 shows one end of a capsule with a miniature ingestible device.

FIG. 11 is a flow process for manufacturing a miniature ingestibledevice.

DETAILED DESCRIPTION

In accordance with the teachings of the present invention, a miniatureingestible device (MID) may be created using excipients and films. Inaccordance with the various aspects of the present invention, aningestible event marker (or an ionic emission module, herein “IEM”) suchas the one disclosed in U.S. patent application Ser. No. 12/564,017,entitled COMMUNICATION SYSTEM WITH PARTIAL POWER SOURCE and filed onSep. 21, 2009, may be covered with a disintegrating or asuper-disintegrating material and/or a disintegrating film using variousmethods of manufacture to produce the MID. The MID, in accordance withvarious aspects of the present invention, may have a coating orlamination surrounding the IEM and separating and isolating the IEM fromthe pharmaceutical product or drug within the capsule once the capsuleis ingested as well as from the capsule itself as the capsule wallsbegin to collapse during the disintegration process. In various aspects,the MID or device can be co-encapsulated with an active agent in a gelcapsule, or other capsule or carrier. The subject compositions includean active agent/carrier component. The term “active agent” refers to acomposition, which may be a solid or fluid, e.g., liquid, which has anamount of active agent, e.g., a dosage, present in a pharmaceuticallyacceptable carrier. The active agent may comprise, for example, apharmaceutical product such as a tablet, capsule, softgel, powder, andother medicament forms.

Referring now to FIG. 1, a capsule 10 includes a product 12 with acavity 14. As understood in accordance with the present invention, theproduct 12 may be any pharmaceutical product or active agent. Alsowithin the cavity 14 of the capsule 10 is a miniature ingestible device(MID) 20. The cavity 14 may also be filled with any excipient orproduct, in accordance with the teaching of the present invention. Thecapsule 10 is made of a dissolvable/disintegrating material, such asgelatin or hydroxypropyl methylcellulose (HPMC) material. Upon ingestionand contact with fluid, the walls of the capsule 10 turn into a softgel-like material, due to contact with fluids.

Referring now to FIG. 2A, in accordance with one aspect of the presentinvention, a MID 20 a is shown with an excipient material 22 asurrounding an IEM 24. The scope of the present invention is not limitedby the type of electronic device positioned within the excipientmaterial 22 a. Any electronic device may be used. Furthermore, the scopeof the present invention is not limited by the type of excipientmaterial used. For example, in accordance with one aspect of the presentinvention, the excipient material 22 a may be a disintegrating materialor a super disintegrating material. Example of materials include, butare not limited to, crospovidone disintegrants (e.g., Kollidon®disintegrants from BASF), polyvinyl polymer distintegrants, (e.g.,Polyplasdone® disintegrants), croscarmellose sodium disintegrants (e.g.,Ac-Di-Sol® distintegrants), sodium starch glycolates (e.g., Primojel®disintegrants, Explotab® disintegrants, and Vivastar® disintegrants),povidone, starch, and microcrystalline cellulose cellulose.

The MID 20 a, in accordance with another aspect of the presentinvention, may be coated with a soluble polymer or film, such as HPMC orhydro hydroxypropyl cellulose (HPC) or blends thereof, whose function isto further delay the dissolution or disintegration of the tablet toallow for a delayed or timed separation of the IEM 24 from the capsule,such as capsule 10 of FIG. 1. Examples of the film materials may includeany one or combination of the following: HPC, polyethylene oxide (PEO),forms of sugar such as sucrose or dextrose, sugar-alcohol such asMannitol or Zylitol. To the film material additional materials may beadded, including any one or combination of the following: plasticizerand/or salt, which includes sodium, potassium chloride, or any ediblesalt compound. Thus, in accordance with various aspects of the presentinvention, examples of the film materials include, but is not limitedto: a combination of HPC and plasticizer with any one of PEO, sugar, orsugar-alcohol; a combination of HPC and plasticizer, a combination ofPEO and plasticizer, and any of the foregoing combinations with salt.The scope of the present invention is not limited by the exact chemicalcomposition of the film material and any combination of the above may beused to produce the film material as discussed in the present invention.

Referring now to FIG. 2B, in accordance with another aspect of thepresent invention, an MID 20 b is shown with the excipient material 22 asurrounding the IEM 24. Furthermore, the MID 20 b includes a filmmaterial 32 positioned on the top surface and bottom surface of MID 20 band physically in contact with or laminated to the excipient material 22a. In accordance with another aspect of the present invention, the filmmaterial 32 is soluble and disintegrates upon contact with fluid. Inaccordance with another aspect of the present invention, the filmmaterial 32 does not disintegrate upon contact with fluid. The MID 20 bis manufactured such that the excipient material 22 a is exposed on theends as shown, in accordance with another aspect of the presentinvention.

Referring now to FIG. 2C, in accordance with another aspect of thepresent invention an MID 20 c is shown with a film material 22 csurrounding the IEM 24. In accordance with another aspect of the presentinvention, the film material 22 c disintegrate upon contact with fluid.The film material 22 c may be made of and includes the followingexamples: at least one of polyethylene oxide and hydroxypropyl cellulosewith a plasticizer comprising at least one of triethylcitrate, glycerol,dibutyl sebacate, and polyethylene glycol.

Referring now to FIG. 2D, an MID 20 d in shown with an excipientmaterial 22 a in a preformed shape. The excipient material 22 a is gluedor laminated onto the IEM 24 using a material 30. The material 30 may bea liquid adhesive or a dry adhesive that is pressure sensitive. Theexcipient material 22 a is shown in a dome like shape with an air gapbetween the excipient material 22 a and the IEM 24. However, the scopeof the present invention is not limited by the shape of the excipientmaterial 22 a or the distance separating the excipient material 22 afrom the IEM 24. In accordance with other aspects of the presentinvention, the excipient material 22 a may be shaped to fit thedimension of the IEM 24 exactly on the inner surface and maintain a domeor convex shape on the exterior. This is helpful in the handling andassembly process of the MID 20 d into the capsule, such as shown in FIG.1 given that many of the pharmaceutical manufacturing facilities aredesigned to handle convex shaped objects.

Referring now to FIG. 2E, an MID 20 e includes a film 22 e surroundingthe IEM 24. The MID 20 e is shown with a gap 26 separating the IEM 24from film 22 e. The scope of the present invention is not limited by thetype of material used to make the film 22 e. The film 22 e is similar tothe film 32 of FIG. 2B and may be made of any suitable material,including but not limited to: of polyethylene oxide and hydroxypropylcellulose with a plasticizer comprising at least one of triethylcitrate,glycerol, dibutyl sebacate, and polyethylene glycol. The scope of thepresent invention is not limited by the size of the gap 26. Inaccordance with another aspect of the present invention, the gap 26 maybe minimal so that portions of the film 22 e are in contact with the IEM24. In accordance with another aspect of the present invention, the gap26 may be filled with a material or a drug as appropriate.

Referring now to FIG. 2F, an MID 20 f is shown with an IEM 24 surroundedby a film 22 f. The film 22 f is surrounded by the excipient material 22a. As shown, the film 22 f is in direct contact with the IEM 24 andsurrounds the IEM 24. Furthermore, the MID 20 f is shown with theexcipient material 22 a surrounding and in contact with the film 22 f.

In accordance with the teaching of the present invention, the shape ofthe various MIDs 20 shown through FIGS. 2A, 2B, 2C, 2D, 2E, and 2F asillustrative and not intended as a limitation. For example, the shape ofthe MID 24, in accordance with various aspects of the present invention,may be oval or rectangular or something in between, for example,vertical sides and convex top and bottom.

Referring now to FIGS. 3, 4, and 5, a capsule 10 is shown with an MID20. There may be other materials, including pharmaceutical material ordrugs or active agents, inside the capsule 10. However, for the purposeof demonstrating the designation steps of the capsule and the MID 20,only these two elements are shown. In FIG. 3 the capsule 10 is shownwhen it is stored and not in contact with fluid. Once the capsule 10comes into contact with fluid, the capsule 10 begins to disintegrate andthe walls of the capsule 10 start to collapse to become capsule 10 a.Fluid AA enters the cavity defined by the capsule 10 a. As such, fluidBB comes into contact with MID 20. In accordance with one aspect of thepresent invention, the excipient material of the MID 20 begins todissolve and expand and the MID 20 starts to lose its shape and becomesthe MID 40. As shown in FIG. 5, at a more advanced stage with longercontact with the fluid AA that entered the capsule 10, the capsule 10 isshown with the walls falling apart and collapsing as capsule pieces 10b. The fluid advances to contact the MID 20 as fluid BB to resulting infurther expansion and disintegration of MID 20, which is shown as MID50.

Referring now to FIG. 6, a process for creating an MID, in accordancewith one aspect of the present invention, includes loading an excipientmaterial 60 a into a press 62. The mass of the excipient material 60 aused is in the order of 0.045 g of powder material. However, the scopeof the present invention is not limited by amount of material used. TheIEM 24 is placed in the press 62. Then additional excipient material 60b, similar in mass to the amount of excipient material 60 a, is addedinto the press 62 and on top of the IEM 24. Then a plunger 64 is used toapply pressure and assemble the materials into the MID, such as the MID20 a of FIG. 1. The pressure used to assemble the MID varies and thescope of the present invention is not limited thereby. Industry standardcombined with the tolerances for the amount of pressure that can beapplied the IEM 24 are the deciding factors. In accordance with oneaspect of the present invention, typical pressures are in the order of1000 psi.

Referring now to FIG. 7, a process for creating an MID, in accordancewith one aspect of the present invention, includes placing a filmmaterial 70 on a press table 72. The IEM 24 is placed on top of the filmmaterial 70 and another sheet of film material 70 is place on top of theIEM 24. The film material 70 is sized such that edges 70 a, 70 b, 70 c,and 70 d extend beyond the edges of the IEM 24. Then a thermal plunger74 is used to apply pressure and heat to the film material 70 such thatthe edges 70 a and 70 b are laminated or secured together. Similarly,the edges 70 c and 70 d are laminated together.

Referring now to FIG. 8, a process for creating an MID, in accordancewith one aspect of the present invention, includes placing a filmmaterial 80 on a press table 82. An internal MID 20, such as the onecreated by the process shown in FIG. 6, is placed on top of the filmmaterial 80 and another sheet of film material 80 is place on top of theinternal MID 20. The film material 80 is sized such that edges 80 a, 80b, 80 c, and 80 d extend beyond the edges of the internal MID 20. Then athermal plunger 84 is used to apply pressure and heat to the filmmaterial 80 such that the edges 80 a and 80 b are laminated or securedtogether. Similarly, the edges 80 c and 80 d are laminated together.

Referring now to FIG. 9, the process for creating an MID 96, such as theMID 20 b of FIG. 2B, includes the process of placing a film material 90,similar to the film material disclosed throughout the present invention,on a press table 92, similar to the press table 72 of FIG. 7. Then asecond film 90 is placed on top of the MID 20. Then a thermal plunger 94is used to apply pressure and heat to the film materials 90 to securethe film material to the top and bottom of the MID 20, which results inthe MID 96 with the side edges exposed.

Referring now to FIG. 10, the MID 96 of FIG. 9 is placed within one endof the capsule 10, such as the capsule 10 of FIG. 1, in accordance withone aspect of the present invention. The MID 96, includes film materials90 that do not dissolve or are not soluble. As such, when the fluidcomes into contact with the MID 20, the MID 20 expands and breaks apartthe walls of the capsule 10 to further ensure separation of the IEM 24,which is within the MID 20, from the capsule material.

Referring now to FIG. 11, the process for manufacturing or assemblingthe MID, such as the MID 20, in accordance with the present inventionbegin at step 1110. At step 1120 the first material is added to theassembly unit. As noted above the first material may be in powder formor a film material and loaded into a press on placed on a press table,respectively. At step 1130, the device, such as the IEM, is loaded intothe assembly unit. At step 1140 a second material is added. At step 1150the assembly in completed by securing the materials and the device toform the MID. As noted above, securing may be done with pressure,thermal, or glue materials. The scope of the present invention is notlimited by the approach used to secure and produce the MID.

As noted above, the film material may be made of a variety of materialsor films, such as polymer films that include polyethylene oxide,hydroxyprpyl cellulose, and triethyl citrate. Other films that can beused include any solulable polymer, plasticizer. The film material, inaccordance with one aspect of the present invention, provides a moisturebarrier and dissolves under the proper conditions to delay activation ofthe IEM or device. The film layer is designed to provide sufficientdelay in exposure of the device to the surrounding fluids relative tothe disintegration and dispersion of the capsule material and thecontent of the capsule. The film layer may includes the solublematerials, barrier materials (such as lipids, polyvinyl alcohol),processing aids (such as plasticizers, adhesion promoters), andstabilizers. Furthermore, the film may be manufactured via lamination,application of a coating solution or slurry followed by a cure. Inaccordance with other aspects of the present invention, the film orlayer may be formed using dry compression, such as a tablet press.

There are a variety of active agents or pharmaceutical products that canbe placed inside of a capsule. For example, there are FDA approveddrugs, drugs that are disclosed chemically in a patent application or inan issued patent, there are drugs are disclosed in the Orange Book aspart of the approved drug products, and generics. In accordance with theteachings of the present inventions, any one or combination of suchdrugs may be placed within the capsule along with the device. Each ofthose drugs may have a specific and unique impact on the operation ofthe device as well as the disintegration of the film used because of theunique chemical composition. As such, the type of material uses as thefilm material may vary to be compatible to the chemical composition ofthe products used. Thus, the scope of the present invention is notlimited by the type of content of the capsule and the film or coatinglayer around the electronic components of the device.

In accordance with another aspect and benefit of the present invention,the film or coating will also prevent the interaction components of thedevice with the drug inside the capsule and as such the device will notalter or impact the effectiveness of the drug.

As noted above various disintegration materials may be used to surroundthe electronic components. For example, a disintegrant may be sodiumstarch glycolate or a water soluble excipient such as hydroxypropylcellulose. It will also be apparent that the various layers disclosedcan be eliminated or combined depending on the material employed and theproperties thereof.

As described herein, the term “ingested” or “ingest” or “ingesting” isunderstood to mean any introduction of the system internal to thein-vivo. For example, ingesting includes simply placing the product inthe mouth all the way to the descending colon. Thus, the term ingestingrefers to any instant in time when the system is introduced to anenvironment that contains a conducting fluid. Another example would be asituation when a non-conducting fluid is mixed with a conducting fluid.In such a situation the MID would be present in the non-conduction fluidand when the two fluids are mixed, the system comes into contact withthe conducting fluid and the IEM within the MID is activated. Yetanother example would be the situation when the presence of certainconducting fluids needed to be detected. In such instances, the presenceof the system, which would be activated, within the conducting fluid,could be detected and, hence, the presence of the respective fluid wouldbe detected.

According to another aspect embodiments of the invention may defined inat least one of the following clauses.

Clause 1: A device for placement within a capsule, comprising:

-   an ingestible element; and-   a material in physical communication with at least part of the    ingestible element, wherein the material facilitates physical    separation of the ingestible element from at least a portion of the    capsule during a disintegration.

Clause 2: The device of clause 1, wherein the ingestible unit comprisesan ingestible event marker.

Clause 3: The device of clause 1 or 2, wherein the material comprises adisintegrant and comprises at least one of povidone, crospovidone,croscarmellose sodium, sodium starch glycolate, starch, andmicrocrystalline cellulose cellulose.

Clause 4: The device of clause 3, wherein the super-disintegrant isphysically coupled to the ingestible unit using pressure.

Clause 5: The device of clause 3, wherein the super-disintegrant isphysically coupled to the ingestible unit using an adhesive material.

Clause 6: The device of any of the preceding clauses, wherein thematerial includes a soluble film material that comprises at least one ofpolyethylene oxide and hydroxypropyl cellulose with a plasticizercomprising at least one of triethylcitrate, glycerol, dibutyl sebacate,and polyethylene glycol.

Clause 7: The device of any of the preceding clauses, wherein the filmmaterial is physically coupled to the ingestible unit using thermalapplication.

Clause 8: A unit including a pharmaceutical product, wherein the unit isingestible and activated upon contact with a fluid, the unit comprising:

-   a capsule including a wall, wherein the capsule defines a cavity for    holding the pharmaceutical product and wherein the wall loses its    shape and disintegrates upon contact with the fluid; and-   a device, preferably a device according to any of the preceding    clauses, the device including a partial power source located within    the cavity of the capsule, wherein the device is capable of encoding    information in a current flow, which occurs when the device is    activated as the partial power source contacts the fluid, the device    further comprising:    -   a first surface with a first portion of the partial power        source;    -   a second surface with a second portion of the partial power        source; and    -   a control unit for encoding the information in the current flow,        wherein the control unit is electrically coupled between the        first and second portions of the partial power source; and-   a material positioned over the first portion and the second portion    of the partial power source, wherein the material disintegrates upon    contact with the fluid to provide physical separation between the    device and the disintegrating wall of the capsule.

Clause 9: The unit of clause 8, wherein the material surrounds thedevice and is secured to itself to define a cavity between the materialand the device.

Clause 10: A system for tracking delivery of a pharmaceutical agent, thesystem comprising:

-   a capsule defining a cavity;-   miniature ingestible tablet located in the cavity of the capsule,    the miniature ingestible tablet comprising:    -   an ingestible device according to any of clauses 1-7, preferably        a device in a unit according to any of clauses 8-9, the device        being activated upon contact with a fluid and comprising an        ingestible element and a tablet material in physical        communication with at least part of the ingestible device; and-   a material at least partially surrounding the miniature ingestible    tablet, wherein the tablet material facilitates physical separation    of the ingestible device from at least a portion of the capsule    during a disintegration process.

Clause 11: The system of clause 10, wherein the material and/or thetablet material is a soluble film material that includes at least one ofpolyethylene oxide and hydroxypropyl cellulose with a plasticizercomprising at least one of triethylcitrate, glycerol, dibutyl sebacate,and polyethylene glycol.

Clause 12: The system of clause 11, wherein the material is anon-soluble film material that defines an opening at either end of theminiature ingestible tablet such that when the tablet material comes incontact with the fluid and expands the film material controls thedirection of expansion.

Clause 13: The system of clause 11 or 12, wherein the film materialdelays contact between the fluid and the ingestible device to delayactivation.

Clause 14: A method of manufacturing a device, preferably for assemblyinto a pharmaceutical product to prevent damage to the device and allowfor handling and manipulation of the device during assembly and forreliable activation of the device upon ingestion of the pharmaceuticalproduct, the method comprising the steps of:

-   -   providing a first layer of material;    -   positioning the device including a first portion and a second        portion, wherein the first portion of the device is in contact        with the first layer of material;    -   providing a second layer of material, wherein the second layer        of material is in contact with the second portion of the device;        and    -   securing the first and second material to the device to produce        a miniature ingestible marker.

Clause 15: The method of clause 14, further comprising the step ofphysically associating the miniature ingestible marker with thepharmaceutical product, wherein physically associating the miniatureingestible marker with the pharmaceutical product comprisesincorporating the miniature ingestible marker in a gelatin capsule.

Clause 16: The method according to clause 14 or 15, wherein the deviceis a device according to any of clauses 1-7.

It is noted that, as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order which is logically possible.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it is readily apparent to those of ordinary skill in theart in light of the teachings of this invention that certain changes andmodifications may be made thereto without departing from the spirit orscope of the appended claims.

Accordingly, the preceding merely illustrates the principles of theinvention. It will be appreciated that those skilled in the art will beable to devise various arrangements which, although not explicitlydescribed or shown herein, embody the principles of the invention andare included within its spirit and scope. Furthermore, all examples andconditional language recited herein are principally intended to aid thereader in understanding the principles of the invention and the conceptscontributed by the inventors to furthering the art, and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and embodiments of the invention as well asspecific examples thereof, are intended to encompass both structural andfunctional equivalents thereof. Additionally, it is intended that suchequivalents include both currently known equivalents and equivalentsdeveloped in the future, i.e., any elements developed that perform thesame function, regardless of structure. The scope of the presentinvention, therefore, is not intended to be limited to the exemplaryembodiments shown and described herein. Rather, the scope and spirit ofpresent invention is embodied by the appended claims.

What is claimed is:
 1. A unit including a pharmaceutical product,wherein the unit is ingestible and activated upon contact with a fluid,the unit comprising: a capsule including a wall, wherein the capsuledefines a cavity for holding the pharmaceutical product and wherein thewall loses its shape and disintegrates upon contact with the fluid; anda device including a partial power source located within the cavity ofthe capsule, wherein the device is configured to encode information in acurrent flow, which occurs when the device is activated as the partialpower source contacts the fluid, the device comprising: a first surfacewith a first portion of the partial power source; a second surface witha second portion of the partial power source; and a control unit forencoding the information in the current flow, wherein the control unitis electrically coupled between the first and second portions of thepartial power source; and a material comprising a first part and asecond part, the first part positioned over the first portion withoutcontacting the first portion, and the second part positioned over thesecond portion of the partial power source without contacting the secondportion, the first and second parts both having first and second ends,the first and second ends of the first part coupled to the first portionvia an adhesive, and the first and second ends of the second partcoupled to the second portion via the adhesive, wherein the adhesivedisintegrates upon contact with the fluid to provide physical separationbetween the device and the disintegrating wall of the capsule; whereinthe material is a non-soluble film material that defines an opening ateither end of the device such that when the device comes in contact withthe fluid and expands, the non-soluble film material controls thedirection of expansion.
 2. The unit of claim 1, wherein the materialsurrounds the device and is secured to itself to define a cavity betweenthe material and the device.
 3. The unit of claim 1, wherein thematerial between the first and second ends of both the first part andthe second part is molded to not touch the first portion and the secondportion of the partial power source.
 4. A device for placement within acapsule, comprising: an ingestible unit comprising a first surface and asecond surface opposite the first surface; and a material comprising afirst part and a second part and in physical communication with at leastpart of the ingestible unit, the first part positioned over the firstsurface without contacting the first surface, and the second partpositioned over the second surface without contacting the secondsurface, the first and second parts both having first and second ends,the first and second ends of the first part coupled to the first surfacevia an adhesive, and the first and second ends of the second partcoupled to the second surface via the adhesive, wherein the adhesivedisintegrates upon contact with fluid such that the material facilitatesphysical separation of the ingestible unit from at least a portion ofthe capsule during a disintegration; wherein the material is anon-soluble film material that defines an opening at either end of theingestible unit such that when the ingestible unit comes in contact withthe fluid and expands, the non-soluble film material controls thedirection of expansion.
 5. The device of claim 4, wherein the ingestibleunit comprises an ingestible event marker.
 6. The device of claim 4,wherein the material between the first and second ends of both the firstpart and the second part is molded to not touch the first surface andthe second surface of the ingestible unit.
 7. A system for trackingdelivery of a pharmaceutical agent, the system comprising: a capsuledefining a cavity; a miniature ingestible tablet located in the cavityof the capsule, the miniature ingestible tablet comprising: aningestible device comprising a first surface and a second surfaceopposite the first surface and that is activated upon contact with afluid; a tablet material in physical communication with at least part ofthe ingestible device; and a material at least partially surrounding theminiature ingestible tablet, the material comprising a first part and asecond part, the first part positioned over the first surface withoutcontacting the first surface, and the second part positioned over thesecond surface without contacting the second surface, the first andsecond parts both having first and second ends, the first and secondends of the first part coupled to the first surface via an adhesive, andthe first and second ends of the second part coupled to the secondsurface via the adhesive, wherein the adhesive disintegrates uponcontact with fluid such that the tablet material facilitates physicalseparation of the ingestible device from at least a portion of thecapsule during a disintegration process; wherein the material is anon-soluble film material that defines an opening at either end of theminiature ingestible tablet such that when the tablet material comes incontact with the fluid and expands, the non-soluble film materialcontrols the direction of expansion.
 8. The system of claim 7, whereinthe material delays contact between the fluid and the ingestible deviceto delay activation.
 9. The system of claim 7, wherein the ingestibledevice includes a partial power source, and the ingestible device isconfigured to encode information in a current flow, which occurs whenthe ingestible device is activated as the partial power source contactsthe fluid.
 10. The system of claim 9, wherein the ingestible devicefurther comprises: a first portion of the partial power source; a secondportion of the partial power source; and a control unit for encoding theinformation in the current flow, wherein the control unit iselectrically coupled between the first and second portions of thepartial power source.
 11. The system of claim 7, wherein the materialbetween the first and second ends of both the first part and the secondpart is molded to not touch the first surface and the second surface ofthe ingestible device.